A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 51
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)
研究概览
简要总结
The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.
The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 10 to below 18 years at screening visit
- •Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
- •Have HbA1c >6.5% to ≤11% at screening
- •Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.
排除标准
- •Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
- •After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- •Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
- •Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- •Had chronic or acute pancreatitis any time prior to study entry
- •Female participants who are pregnant or breast feeding or intending to become pregnant.
- •Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
研究组 & 干预措施
Tirzepatide Dose 1
Double-Blind:
Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.
Open-Label:
Participants will continue to receive Tirzepatide at the last dose level
干预措施: Tirzepatide Dose 1 (Drug)
Tirzepatide Dose 2
Double-Blind:
Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached.
Open-Label:
Participants will continue to receive Tirzepatide at the last dose level
干预措施: Tirzepatide Dose 2 (Drug)
Placebo
Double-Blind:
Participants receive placebo during the 30-week double-blind period.
Open-Label:
Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.
干预措施: Tirzepatide Dose 1 (Drug)
Placebo
Double-Blind:
Participants receive placebo during the 30-week double-blind period.
Open-Label:
Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)
时间窗: Baseline, Week 30
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)
次要结局
- Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)(Baseline, Week 30)
- Percentage of Participants Who Achieve <5.7% of HbA1c(Week 30)
- Percent Change From Baseline for Serum Lipid Levels(Baseline, Week 30)
- Change From Baseline in HbA1c (Individual Doses)(Baseline, Week 30)
- Percentage of Participants Who Achieve ≤6.5% of HbA1c(Week 30)
- Percent Change From Baseline in BMI(Baseline, Week 30)
- Change From Baseline in Height Standard Deviation Score (SDS)(Baseline, Week 30)
- Change From Baseline in Fasting Serum Glucose (FSG)(Baseline, Week 30)
- Percentage of Participants Who Achieve <7.0% of HbA1c(Week 30)
- Change From Baseline in Weight SDS(Baseline, Week 30)
- Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale(Baseline, Week 52)
- Change From Baseline PedsQL (3.2) Diabetic Module(Baseline, Week 52)
- Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide(Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.)